Friday, March 1, 2013

Stonewalled by the University of Minnesota again

On February 20, after discovering evidence of duplicate “evaluation to consent” and HIPAA forms apparently originating in the Department of Psychiatry, I submitted a formal request for an investigation to Dr. Frances Lawrenz, the Research Integrity Officer at the university and an Associate Vice-President for Research.  To be honest, I did not expect my request to get a fair hearing, given my experience with other such complaints, but I felt that it was probably a good idea to go through proper procedures anyway. In my letter, I specifically asked Lawrenz not to involve the Office of the General Counsel in her investigation, because of the possibility that the office was involved in the issues that I was asking her to investigate.

Her reply came by email on February 26.

“Dear Dr. Elliot, Thank you for your email and attachment. I have read the material. I did share the information with Barbara Shiels because she is the lawyer assigned to provide advice about research misconduct. I also carefully read our research misconduct policy to determine the fit of your information with the policy. Our research misconduct policy has a 'statute of limitations' of 7 years. (See http://policy.umn.edu/Policies/Research/ACADEMICMISCONDUCT_PROC01.html ) Since the matters covered in your letter occurred more than seven years ago, the material you present is outside the purview of the policy. In addition, your concerns about the consent evaluation process and possible HIPAA violations do not appear to fall under the definition of research misconduct (i.e., alleged fabrication, falsification or plagiarism), regardless of when the events occurred.”

I don’t think I’m alone in finding this reply disturbing, and not just because Lawrenz shared my request with the Office of the General Counsel.  Her citation of the university research misconduct policy is misleading at best, and almost certainly wrong.  Here is what the policy says about the seven year statute of limitations:  “Allegations of misconduct that occurred seven or more years prior to the submission of the allegation will not be investigated unless the circumstances indicate that the alleged conduct was not reasonably discoverable earlier.” In this case, of course, the evidence of duplicate documents only just emerged, so it would have been impossible to request an investigation of this issue earlier.  Yet Lawrenz claims that the seven year limit has expired.

As for the university definition of research misconduct: the policy says that misconduct involves, among other things, “fabrication or falsification of data, research procedures, or data analysis.”  It is hard to see how the “research procedures” for a clinical trial would not include these “evaluation to consent” and HIPAA forms. And of course, the possibility that they were fabricated or falsified was precisely what I was asking her to investigate.  (In fact, as the Board of Social Work documented in its “corrective action” against Jean Kenney, the study coordinator for the CAFÉ study, Kenney routinely falsified the initials of physicians on study records.)

It is responses like this one that have led me to doubt the integrity of human subject protection at the University of Minnesota.  If the university administration were actually concerned about the welfare of research subjects, would it not want to look into these issues?

2 comments:

  1. Carl, the University of Minnesota will never look into these issues because they are scared too death of what they might find, or actually might have already found. It's not rocket science to read the corrective action report against Jean Kenney and come to the conclusion that the study physician Stephen Olson was far more culpable than even Kenney in the cover-up over the death of Dan Markingson. The University at this point has no option but to stay the course of denial, for to give in and admit fault would open the flood gates, and the group of people gathering at the gates grows larger everyday.

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  2. This entire HIPAA issue that Carl is referencing is very clearly defined in the depositions of Dr. Olson and Jean Kenney that I have read on-line, and actually Ms Kenney comes across as more credible than Dr. Olson. Olson's responses are something you might expect a 10 year old to say. I couldn't agree more with what Mike states, and that is if the University actually took the time to investigate and read the published depositions how can they not come to the conclusion that either Dr. Olson was lying throughout his testimony or is nothing more than an complete bumbling idiot that unfortunately had control over very vulnerable and mentally ill patients. At least Jean Kenney admitted some of her mistakes, Dr. Olson it seems from the testimony thought everything was a big joke. As a resident of this state I cannot be more ashamed of the University and it's despicable behavior and treatment of not just the Markingson boy but others that have had to deal with the psychiatry department. Judy and Kevin Matthews

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